BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA XT DR

    MDR report key: 5279626 · Received December 9, 2015

    Report

    Report Number
    2182208-2015-04122
    Event Type
    Injury
    Date Received
    December 9, 2015
    Date of Event
    September 1, 2015
    Report Date
    October 21, 2015
    Manufacturer
    MEDTRONIC, PLC
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THE EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS EVENT FILE. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: TWIDDLERS SYNDROME. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHERE IT WAS REPORTED THAT FOUR WEEKS AFTER IMPLANT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN AND SHORTNESS OF BREATH. CHEST X-RAY AND DEVICE INTERROGATION REVEALED NO SENSING OR PACING CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD OR RIGHT ATRIAL (RA) LEAD. AT SYSTEM EXPLANT IT WAS DISCOVERED THAT THE ENTANGLED LEADS WERE THE RESULT OF TWIDDLERS SYNDROME. THE PHYSICIAN DECIDED AGAINST REPOSITIONING THE LEADS DUE TO CONCERNS WITH A RECURRENCE OF THE CAUSATIVE BEHAVIOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810796 EVERA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, PLC DDBB2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R